Skip to: Clinical Research Scientist, Ethics and Compliance, Health Outcomes, Pharmacoepidemiology, Project Management (Program Phase), U.S. Medical Information Services, U.S. Regulatory Affairs, Application and Selection Process
The Visiting Scientist Program is a one-year, postgraduate program that introduces participants to various medical, marketing, and regulatory aspects of the pharmaceutical industry. It is designed to train professionals for a career in the pharmaceutical industry by allowing them “hands-on” experience with the drug development process. The visiting scientist is assigned to one department yet has continuous contact with other functional areas.
Visiting scientists work in a number of functional areas throughout the company. The positions may differ from year to year based on business needs. The following is a list of the positions that are planned for the 2008-09 program year.
Clinical Research Scientist
- Provide implementation support to enhance the integration of information across the clinical, health outcomes, regulatory, marketing and strategic components of a clinical drug development team
- Contribute directly to a number of key activities linked to drug development, including development and updates to clinical protocols, regulatory documents, health outcomes instruments and reports, competitive landscape and external environment assessments
- Partner with the platform team to develop strategic communication portfolios around the assets seeing developed and contribute to interactions with external partners and collaborators
Ethics and Compliance
- Provide compliance support to US medical, marketing and sales teams, including thorough and timely responses to inquiries
- Support development, communication, training and monitoring of compliance Policies and Procedures for US-based activities in accordance with US laws and regulatory guidance
- Assess needs for communication and training programs
- Facilitate compliance training for US-based personnel (including medical, marketing and sales)
- Conduct compliance monitoring interventions and implement corrective action plans where warranted
Health Outcomes
- Understand the role of Outcomes Research in the drug development and marketing process
- Develop and improve skills in epidemiological, health economic, and quality of life analyses
- Work cross-functionally with marketing teams to identify key issues for analysis
- Collaborate with health Outcomes staff in data analysis, abstract development, poster presentations, and manuscript development
- Contribute to efforts to appropriately communicate health outcomes information
Pharmacoepidemiology
- Understand the process and regulations for adverse events reporting and drug safety
- Design and conduct pharmacoepidemiologic studies to evaluate associations between specific drug exposures and adverse events
- Develop and maintain a repository of information on the burden of illness, incidence and prevalence of key disease conditions specific for Lilly products
- Provide training and technical support in basic principles of epidemiology, public health and drug safety surveillance to internal and external groups
Project Management (Program Phase)
- Coordinate the application and integration of key Project Management processes and tools to deliver team milestones on time, on budget, and within scope for several early phase drug development teams
- Partner with the cross-functional team and the Program Leader to coordinate the creation of an integrated drug development plan or subsets of the plan including scope, budget, timeline, and risk that translate the “label as driver” strategy into operational objectives as well as monitoring performance vs. plan and triggering appropriate control processes for the team(s).
- Effectively manage cross-functional communications, document key team information and decisions, and ensure project management systems are up to date (MS Project, etc.)
- Play a leadership role as a resource to the business with regard to sharing learning, process improvement, and identification of special/complex needs as they pertain to primary responsibilities
U.S. Medical Information Services
- Understand the role of the Medical Information Associate in providing customers with “Answers That Matter” based on collective knowledge of products and understanding of customer needs
- Develop deep expertise on medical and regulatory requirements
- Develop expertise in providing timely, accurate disease state and drug information for internal and external customers
- Work cross-functionally with clinical research physicians and marketing teams to identify key issues for a given product
U.S. Regulatory Affairs
- Understand the FDA regulations and guidance documents and how they apply to the drug development process
- Influence drug development strategies that lead to science and market-driven product labels
- Develop regulatory strategies that will lead to the successful registration of investigational compounds
- Stay apprised of the external environment and potential ramifications on the pharmaceutical industry
- Provide regulatory support for the review and approval of promotional materials and activities by the U.S. Brand Teams
Application and Selection Process
The Visiting Scientist Program is currently recruiting for the 2008-2009 year. Applicants must have completed their PharmD, PhD, MD, or Master’s Degree by May 2008 to be eligible for the Visiting Scientist Program.
Screening interviews are usually conducted at the ASHP Midyear Clinical Meeting. On-site interviews are usually conducted in January and February. The selection process is generally completed by the end of February.
If you have any questions, contact:
David Riggs, PharmD
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285
email: driggs@lilly.com
